You’d think it would be
easy to recruit patients for studies — just put an ad in the paper or talk to
patients at the clinic. Everyone wants to help science advance, right? Maybe,
but that doesn’t mean they want to be a subject in a clinical trial.

According to data reported
in How to Grow Your Investigative Site, by Barry Miskin and Ann Neuer,
published in 2002 by CenterWatch, it now takes about 4,400 patients to bring
a new drug to market. Further, while some 3 million people per year begin studies,
only 700,000 finish what they start.

"About 80% of studies have
to extend enrollment periods by at least a month," says Claire Driscoll,
MBA, executive vice president at CliniCall Patient Recruitment services in St.
John, New Brunswick in Canada.

Her company manages phone
contact with patients and recruits them for studies through a call center. She
has seen many of the mistakes that organizations make regarding patient recruitment.
"One of the biggest problems I see is that people think if they hire a call
center, patient recruitment will go through the roof. That’s a misconception,"
she says. "It’s only one part of a well-rounded strategy that you have to create
before you even begin a study."

Indeed, problem No. 1 according
to Driscoll, is most investigators and coordinators have no recruitment strategy
at all. "A lot of people think they can choose just one thing, like putting
ads in the paper or doing Internet recruitment. Worse, they’ll say they’ll just
let the investigators do it for a while, and then if they run into problems,
they come to us."

That creates some large
challenges, she says. First, if it is a rescue effort, costs go up and time
becomes critical. Money may become even more of an issue if the investigator
did not budget for the contingency.

"You can’t just try stuff
willy-nilly," Driscoll says. "Start at the beginning, figure out who you are
trying to reach, and create an appropriate strategy for getting to them." Recruitment,
she adds, should be one of the first things an investigator and trial administrator
discuss.

"A lot of investigators
just kind of assume that recruitment will happen," says Beth Harper,
MBA, senior vice president of global operations at Diane Anderson Company, a
clinical trials consulting firm based in Dallas that specializes in patient
recruitment.

Start with an in-depth
assessment of the study and the targeted patient population, she says. "Make
sure you have gone through any database of patients to identify patients who
might meet criteria from the start."

Next, consider other physicians
or investigators in your community who also might know some good potential patients,
Harper says. "If you have a network, tap into it."

Only then should you consider
which outside resources to use. Among potential strategies: advertising, placement
of articles in the paper, and attendance at local health fairs, Harper continues.
"Understand the potential sources for your patients and then put in place a
plan for reaching them. Before you begin, estimate how much time it will take,
what materials you’ll use, and how much money you’ll need to recruit the patients
you require."

Harper says a frank discussion
with the sponsor about resources required is a must. "Will you have to hire
someone to go through charts and databases? Do you think you’ll need to hire
a call center? How much will you need for advertising?" Getting additional funds
after the study starts will be much harder than answering those questions at
the beginning and asking the sponsor for the appropriate funds then.

Another requirement: Make
sure you get your recruitment materials approved early. It can take as long
as four months, says Harper. "People often think if they just get through the
regulatory paperwork, they’ll be fine. But there are often materials that the
ethics committee will have to approve, too."

Another problem Driscoll
commonly sees is an overestimation of what it takes to get people involved in
a trial. "Investigators will tell you they know 15 people who would be just
great for the study. But converting good candidates into people who want to
participate in a clinical trial is neither easy nor instant," she says. "Chances
are you won’t convince all 15 of them."

If you are overseeing a
multisite study, be sure to keep in touch with all the sites and monitor how
recruitment is going at each. If one particular site is having trouble getting
its share of patients, knowing early will help to identify the problem and correct
it before your study becomes one of that 80% seeking an extension on the enrollment
period.

Harper says administrators
and investigators should have weekly meetings about recruitment to see where
a study stands and what action, if any, needs to be taken to keep recruitment
on track.

Large organizations, such
as universities and academic medical centers also may have resources available
to assist in patient recruitment. For instance, they may be able to help set
up an Internet site to prescreen subjects or provide a toll-free number for
screening.

If you do end up using
a call center or other organization to help with recruitment, make sure your
expectations of what they can do and how fast they can help are not unrealistic.
"We can only generate referrals based on the calls we get, and the media planning
drives that. If we’ve done the media part of the recruitment, too, it’s not
as much of an issue. But if the media doesn’t target the right people then we
might get hundreds of calls but few appropriate patients."

Part of what drives how
successful efforts are is the difficulty of the protocol. If it’s a simple one,
the screen might take under a minute, and 200 calls can generate 150 potential
patients. But harder protocols can require 500 people screened to get the same
number of prospective subjects.

Call centers also may offer
other services that can help with patient retention. For instance, CliniCall
offers appointment setting and appointment reminder services, says Driscoll.
"If they offer services like that, take advantage of them."

The costs for these services
will vary widely, depending on the complexity of the study, the time frame in
which recruitment needs to be completed, and any ancillary services you opt
to sign up for. Regardless of what you choose to use, make sure you check references.
"If you ask and they won’t give you numbers to call, I would go elsewhere,"
Driscoll says.

Harper says letting a recruitment
service know about your past recruitment efforts is key to building a successful
relationship. "They should know what has worked for you in the past and what
hasn’t," she says.

The more you work with
the company, the better the campaign will be. You can even work with them on
the prescreening script, adds Harper. "Provide good feedback. Tell them how
you want the relationship to work, what you need to see in advance, and if you
have any good contacts for advertising."

Once you have a potential
subject, keeping them involved in the study is often based on making sure they
have a realistic understanding of the study. Harper says many patients enroll
in studies because they think they’ll be getting extra care with a physician.
"Make sure that the reality and the message are the same."

Their experience in the
study also must be good, and Harper says that means making sure that there is
enough staff to handle the patients. "Don’t take on more than you can realistically
do," she says.

In the end, there is no
magic formula, Harper points out.

"People always ask me what
kind of ad design makes for the best recruitment. But that isn’t what makes
something work. It’s the non-glamorous stuff like planning that will bring success.
The rest is tactics and strategies. And those don’t matter if you don’t have
a good plan, adequate resources, and a willingness to work hard."

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